BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIGASURE BLUNT TIP LAP SEALER/DIVIDER

    MDR report key: 3912821 · Received June 25, 2014

    Report

    Report Number
    1717344-2014-00541
    Event Type
    Death
    Date Received
    June 25, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 18, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SITE HAS INDICATED THAT THE INCIDENT SAMPLE HAS BEEN DISCARDED. ADDITIONAL QUESTIONS IN REGARD TO THE INCIDENT HAVE ALSO BEEN ASKED. IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO HAVE OBSERVED BLEEDING FROM A "PINHOLE" SIZED OPENING THAT WAS BEHIND THE CONJUNCTION OF THE SUPERIOR VENA CAVA AND AZYGOS VEIN DURING AN EXCISION OF MEDIASTINAL LESION AND THORACOSCOPY PROCEDURE. THIS WAS NOTICED WHEN THE SURGEON WAS USING THE LIGASURE DEVICE TO GRASP AND DISSECT A NEARBY STRUCTURE. THE OPENING WAS SUTURED AND THE SURGERY WAS EXTENDED BY MORE THAN 30 MINUTES. HOWEVER, THE SUTURED AREA WAS TORN OPEN AND ADDITIONAL BLEEDING OCCURRED, WHICH RESULTED IN THE DEATH OF THE PATIENT. THE ISSUE OCCURRED WHILE THE LIGASURE DEVICE WAS IN USE BUT THE SITE HAS NOTED THAT THE DEVICE WAS NOT RESPONSIBLE FOR THE BLEEDING. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. ADDITIONAL QUESTIONS IN REGARD TO THE INCIDENT HAVE BEEN ASKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369736 LIGASURE BLUNT TIP LAP SEALER/DIVIDER LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death